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Legalization's opening of medical pot research is dream and nightmare

Charlotte Figi, 7, with mother Paige, was the first youth in the state to use medical cannabis oil to help with her epilepsy symptoms. Paige Figi says her daughter's seizures have been reduced from nearly 1,200 a month to fewer than 50. (AAron Ontiveroz, The Denver Post)

Desperate parents are flocking to Colorado in search of pot-derived medical treatments they consider a last resort, yet many researchers are alarmed by parallels to past miracle-cure manias later proved false.

Accelerating legalization sentiment across the nation could open doors to legitimate medical research, testing marijuana products blocked for decades by federal law.

But the movement also opens the way for bad medicine, researchers said, through treatments at best giving hope to the hysterical and at worst delivering damaging side effects.

Is legalization a scientist's dream or a doctor's nightmare?

Charlotte Figi, 7, has seen her epileptic seizures reduced with treatment of cannabidiol. "I know what we're doing is not the FDA path, but it just got me two more years with (Charlotte)," her mother, Paige, says. (AAron Ontiveroz, The Denver Post)

"Yes to both," said Dr. Edward Maa, a neurologist and epilepsy researcher at the University of Colorado School of Medicine, who supports some of the freelance marijuana efforts in health care but also says derivatives should be studied more rigorously.

Some of the children coming to Colorado suffer new stresses and seizures from the altitude, from parents changing jobs or losing hometown social-service support.

"They're ending up at the Children's Hospital ICU and other places," Maa said.

"The mania needs to calm down. I've never seen this level of frenzy," said Dr. Orrin Devinsky, director of the epilepsy center at New York University's Langone Medical Center. Devinsky has one of the few clinical trials ever approved in the U.S. for a marijuana derivative, cannabidiol, and receives hundreds of calls from beseeching parents after publicity about Colorado epilepsy cases.

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Longtime researchers are struck by the openness of current parents to marijuana derivative treatments, Devinsky said.

"There's a comfort level" among those who have used or been around marijuana for a generation, he said.

By contrast, Devinsky said, "There's a group of medical leaders that are appalled by what's going on."

Colorado's status as "ground zero" for new, unauthorized research went national in recent months with news coverage of a few hundred children with untreatable seizures taking cannabidiol made by a Colorado Springs dispensary.

Doctors agree with parents such as Paige Figi that their children were suffering crippling, life-threatening seizures by the dozens, a regressive condition proved untreatable by current medicine. Paige and Matt Figi heard of cannabidiol's proven ability to bind with key brain receptors and tried it on daughter Charlotte.

The refined and dosage-tested oil has low THC and therefore no psychoactive effects. In Web videos, on national TV and in local interviews, Paige Figi describes how 7-year-old Charlotte has gone from suffering 1,200 seizures a month and a devastating regression from walking and eating, to resuming happy childhood moments on a park playground in north Colorado Springs.

"I literally couldn't watch another minute of her suffering," Paige Figi said of the moment two years ago when they first tried the oil. Now she is among volunteer parent advocates pushing for medical marijuana legalization in New York and other states as part of an effort to broaden the experiments.

Figi acknowledges and agrees with doctor precautions about unproven medicines, and says she always calls for rigorous testing. Yet she quickly adds a doctor's standard is different from the judgment of a parent whose child is dying a slow and violent death.

On a recent sunny afternoon in Fox Run Regional Park, Charlotte sat on a sled and ate grapes while her fraternal twin sister and her brother played nearby. The back of the car had grocery bags with eggs and paper towels from an errand along the way.

Two years ago, Paige said, the family's run to the store would have ended with Charlotte seizing on the ground amid broken eggs and terrified store managers dialing an ambulance.

"I do believe in a (Food and Drug Administration) clinical trial model," Figi said. "I just didn't have time to wait for that."

Remarkable progress

Interest in cannabidiol increased last week with the release of a scientific study abstract by Maa and Colorado Springs physician Dr. Margaret Gedde, who advises many of the epilepsy patients using it in Colorado.

Gedde and Maa's research showed parents of a handful of traumatic-seizure children reporting remarkable improvement on cannabidiol, or CBD. Eight of 11 families had "sharp reduction patterns in intractable seizures," Gedde said in an interview.

Maa is taking the results to a Colorado medical research review board to gauge the plausibility and the interest in supporting safety and clinical trials in the state.

The waiting list grows daily for hard-to-produce CBD, now called Charlotte's Web, produced by a legal dispensary run by the Stanley family in Colorado Springs. Parents who move here to get it can't return to their home states, as the substance is illegal across most state borders.

The FDA has approved only a couple of marijuana derivatives for prescription drug use, including tablets for treating nausea and lack of appetite in cancer patients and those with other wasting diseases. Proponents of marijuana medications, with the support of some mainstream lab research, say promising applications for derivatives include immune disorders, inflammation and psychotic mental illnesses.

But researchers warn that without loosened federal restrictions and then years of sanctioned clinical trials, there are few ways to prove those claims. Studies also need to isolate which of many compounds produced by marijuana plants are the key ingredients to medical treatment.

In the scientific and medical worlds, a parent and a doctor claiming to observe success is vastly different from the high standards of a clinical trial. In such stringent, FDA-controlled tests, neither the patients nor their treating doctors know who is given CBD, for example, and who is given a placebo.

"Observational data is regarded as fairly low quality in the hierarchy of things," said Dr. J. Michael Bostwick, a Mayo Clinic psychiatrist who has written a survey of research into medical marijuana claims titled "Blurred Boundaries."

Major placebo effect

Clinical researchers are wary of the heightened placebo effect in treatments involving children, when reports of progress depend on the view of parents — and even their family physicians — desperate for hope.

Justin and Annie Koozer uprooted their family from Tennessee to pursue cannabidiol in Colorado for their 2-year-old daughter, Piper. Yet Justin Koozer, too, worries about trying to see too much progress in Piper's intense seizures since she started taking the oil in late October.

Piper suffers from Aicardi syndrome, missing a crucial bundle of fibers attaching the brain hemispheres. After trying every other recommended drug with little impact, the most Koozer will say about CBD is that Piper has improvements that are "unquantifiable." She's having seizures, but fewer of them; she sleeps through many nights, a huge change.

"She can tolerate exercising and playing with toys much longer," Koozer said.

Still, he knows the risk of the placebo effect in experimental treatments.

"You've pulled up stakes and moved out here, and people around you are saying it's working, and you want to be part of that," he said. "We have to be careful of that."

Those urging caution on cannabidiol note the evocative reputations of past frenzy-driven treatments such as "laetrile" and "Lorenzo's oil." Both allegedly miraculous treatments caught the American fancy, in part from their "natural" components, only to have their effectiveness and safety dismantled by clinical research.

Gedde said she comes from a pharmacological research background herself and is committed to pushing derivatives toward clinical trials.

The FDA, she said, has approved many medications that proved safe and effective, before scientists knew exactly what mechanism made them effective.

"People like to believe we know everything about approved drugs, but that's just not the case," she said.

Licensing special strain

Gedde, Maa and other doctors worry that dispensaries less careful than the Stanley brothers' Indispensary and Realm of Caring are promoting marijuana products with widely varied dosages of CBD. The Stanleys have theirs tested to calibrated milligrams in labs, Maa said.

Joel Stanley said publicity over Charlotte's Web adds to their waiting lists for the oil every day. They get requests from marijuana adventurers who want to try the oil for nonmedical reasons, Stanley said, but they restrict their limited supply to seizure patients.

The next step is licensing their special strain of high-CBD marijuana varieties to responsible growers in other states and countries, he said.

The Stanleys say they produce the oil at a loss, which they are willing to absorb. Joel Stanley sounds more exhausted by keeping up with production than worries over hyped medical claims.

"We're very objective. We're not a bunch of potheads. We're not making claims," he said. "We're simply sharing what we're seeing."

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